New painkillers stalk Zohydro

The abuse-deterrent hydrocodone market looks like it will be getting tighter: drugmaker Purdue Pharma announced Wednesday that it was submitting an NDA to the FDA for review of its experimental extended-release hydrocodone bitartrate tablet.

The once-daily tablet has abuse-deterrent properties, unlike the controversial pain medication Zohdryo, which is made by Zogenix, and has been a flashpoint for lawmakers who have urged the FDA to withdraw its approval.

Purdue's senior director of public affairs, Jim Heins, told MM&M he would not characterize the recent submission as an answer to Zohydro, because the company has been working on the abuse-deterrent formulation for some time.

Teva is also getting into the abuse-resistance conversation. The company announced Wednesday that it has launched Phase-III studies of its extended-release hydrocodone bitartrate medication for patients with chronic low back pain. Teva plans to file an FDA review application at the end of this year.

Prescription painkiller abuse has become a rampant health problem, so much so that Massachusetts tried—and failed—to implement a ban on Zohydro prescriptions in an effort to curtail category abuse. With Zohydro, the concern has been that it is easily abused, but the opioid category as a whole has made states wary.

Acting Director of the Office of National Drug Control Policy Michael Boticelli told a House Energy and Commerce subcommittee yesterday that 4.9 million Americans ages 12 and up reported using prescription painkillers for non-medical purposes within the last month. Boticelli said this makes “pain reliever misuse more common than use of any type of illicit drug in the United States except for marijuana.”

He also noted that, while heroin use has remained low in the US, there has been a troubling increase. The number of heroin users reached 669,000 in 2012, compared to 373,000 five years ago. This is of note because a migration from prescription pain medications to cheaper heroin has become a documented pattern.

The FDA has defended its approval of Zohdyro, but as Bloomberg noted in March, the agency has an out which is that the regulator can pull its endorsement if an abuse-deterrent alternative became available.

Even if the FDA were to approve a less easily abused hydrocodone medication, the category will still expand. Heins explained that doctors who treat chronic pain medications need an array, “particularly because one type of medication might become ineffective or might not be well tolerated by the patients, or they need to try something else.”